Otsuka Pharmaceutical Co., Ltd.
Otsuka Holdings Co., Ltd.

Otsuka Pharmaceutical Files for Additional Indication Regulatory Approval in Japan for ABILIFY_®, a Treatment for the Manic Symptoms Associated with Bipolar Disorder

Tokyo, Japan, January 24, 2011 -- Otsuka Pharmaceutical Co., Ltd. today announced that it has applied for additional indication regulatory approval in Japan for ABILIFY_® (aripiprazole), a treatment for the manic symptoms associated with bipolar disorder.

Otsuka Pharmaceutical commenced marketing ABILIFY in Japan in June 2006 as a treatment for schizophrenia. ABILIFY is currently sold in five formulations, ABILIFY Tablets 3 mg, ABILIFY Tablets 6 mg, ABILIFY Tablets 12 mg, ABILIFY Powder 1% and ABILIFY Oral Solution 0.1%.

Bipolar disorder, which is also referred to as manic- depressive psychosis, is said to have a lifetime prevalence of 0.4%^*. Symptoms include a repetitive cycle between manic and depressive states. A manic state is defined by the presence of abnormally elevated energy levels and impaired judgment. In a large number of cases, the individual is unaware of any illness and is unlikely to seek assistance. Signs and symptoms of the depressive phase on the other hand, include strong feelings of despair. Individuals with this condition will oftentimes seek the support of others. Unable to accept or deal with the reality of the situation, depression can also lead to feelings of hopelessness. In the case of mixed episodes or states, the features of both mania and depression are present at the same time. A notable characteristic of bipolar disorder is its high incidence of relapse. Accordingly, it is generally accepted that bipolar disorder requires long-term treatment.
This application for additional indication approval is for a treatment for the manic symptoms associated with bipolar disorder.

• * Research relating to the epidemiological study of health science: Fiscal 2006 Health and Labour Sciences Research Grant (Health Science)

ABILIFY^® is described as a dopamine system stabilizer (DSS). It exerts an inhibitory action when large amounts of dopamine are released in the brain and a stimulatory action when only small amounts are released, thus stabilizing dopamine neurons. This mechanism enables the drug to improve both the positive and negative symptoms of schizophrenia which are thought to be induced by dopamine abnormalities. At the same time, the drug can be used for long-term continuous treatment as it is less likely to cause drowsiness or weight gain. To date, ABILIFY is sold in 65 countries and regions worldwide including Japan with global sales of approximately 370 billion yen in fiscal 2009.

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